Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009
The researchers believe that the multifunction Keito devices shares with TANITA TBF-300 (K014009) the same efficacy on the body fat measurement. Even if the body contact points are not the same, the researchers deeply believe that the tetrapolar BIA used by the predicate gives results as similar as the multifunction keito does.
|Study Design:||Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||October 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
177 volunteers were enrolled in this clinical Study. Before taking the fat measurement by the devices under test, the observers measured the weight and height of each volunteer prior to measure the body fat. This was done to configure a preliminary idea about the body composition of the subject.
Both devices are designed by the same technology to emit a low current through the body, and finally make a measurement of the impedance found between the body contact points. We expected the results to be very similar.
|Aguiflai Iberica, s.l|
|Vilassar de Mar, Barcelona, Spain, 08340|
|Principal Investigator:||Angel P Ferre, Telecommunications Engineer||Aguiflai Iberica, S.L.|